Download as PDF
Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Proposed Rules
FOR FURTHER INFORMATION CONTACT:
Samir Assar, Center for Food Safety and
Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–1636.
SUPPLEMENTARY INFORMATION:
daltland on DSKBBV9HB2PROD with PROPOSALS
I. Background
We are announcing the availability of
a draft guidance for industry entitled
‘‘Standards for the Growing, Harvesting,
Packing, and Holding of Produce for
Human Consumption.’’ We are issuing
the draft guidance consistent with our
good guidance practices regulation (21
CFR 10.115). The draft guidance, when
finalized, will represent the current
thinking of FDA on this topic. It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternate approach if it
satisfies the requirements of the
applicable statutes and regulations. This
guidance is not subject to Executive
Order 12866.
We intend to conduct four public
meetings in diverse regions of the
United States to discuss the draft
guidance, and we will provide details
about these public meetings in a notice
published in the Federal Register.
The Produce Safety Rule (80 FR
74353) established science-based
minimum standards for the safe
growing, harvesting, packing, and
holding of produce grown for human
consumption. The rule sets forth
procedures, processes, and practices
that minimize the risk of serious adverse
health consequences or death, including
those reasonably necessary to prevent
the introduction of known or reasonably
foreseeable biological hazards into or
onto produce and to provide reasonable
assurances that the produce is not
adulterated on account of such hazards.
Requirements of the rule focus on major
routes of contamination, including
health and hygiene; biological soil
amendments of animal origin;
domesticated and wild animals; and
equipment, tools, and buildings.
This draft guidance provides
recommendations, examples, and
information related to compliance and
implementation of the following
subparts of the Produce Safety Rule:
Subpart A—General Provisions
Subpart C—Personnel Qualifications
and Training
Subpart D—Health and Hygiene
Subpart F—Biological Soil
Amendments of Animal Origin and
Human Waste
Subpart I—Domesticated and Wild
Animals
Subpart K—Growing, Harvesting,
Packing, and Holding Activities
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Subpart L—Equipment, Tools,
Buildings, and Sanitation
Subpart O—Records
Subpart P—Variances
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
This draft guidance is based on FDA’s
current thinking and we believe that
additional information would assist us
in developing the final guidance. While
we invite comments on all aspects of the
draft guidance, we seek specific
comments, information, and data on the
following:
For equipment and tools intended to
or likely to contact covered produce:
• When acquiring equipment and
tools, how do you engage with
equipment and tool suppliers about the
size, design, and construction of your
buildings so that they can accommodate
the equipment and tools?
• What information or data can you
provide about cleaning, sanitizing, and
maintenance practices and procedures
for equipment and tools that have wood,
foam, or other porous or absorbent
materials?
For domesticated and wild animals:
• What data or information can you
provide about factors or conditions that
would affect the likelihood of
contamination of covered produce by
animals? Such factors include, for
example, historical information and
conditions on or near farms that
influence animal habitats.
21 CFR Part 117
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 112 have
been approved under OMB control
number 0910–0816.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/FoodGuidances or
https://www.regulations.gov. Use the
FDA website listed in the previous
sentence to find the most current
version of the guidance.
Dated: October 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–23006 Filed 10–19–18; 8:45 am]
BILLING CODE 4164–01–P
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Food and Drug Administration
[Docket No. FDA–2018–D–3583]
Guide To Minimize Food Safety
Hazards of Fresh-Cut Produce: Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notification of availability.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the availability of a
draft guidance for industry entitled
‘‘Guide to Minimize Food Safety
Hazards of Fresh-cut Produce.’’ The
draft guidance, when finalized, will
supersede a previous guidance, entitled
‘‘Guide to Minimize Microbial Food
Safety Hazards of Fresh-cut Fruits and
Vegetables,’’ that we issued in 2008. The
draft guidance is intended to explain
our current thinking on how to comply
with recently modernized requirements
for current good manufacturing practice
(CGMP) and with new requirements for
hazard analysis and risk-based
preventive controls under our regulation
entitled ‘‘Current Good Manufacturing
Practice, Hazard Analysis, and RiskBased Preventive Controls for Human
Food’’ during the production of freshcut produce.
DATES: Submit either electronic or
written comments on the draft guidance
by April 22, 2019 to ensure that the
Agency considers your comment on the
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
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53198
Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Proposed Rules
daltland on DSKBBV9HB2PROD with PROPOSALS
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–D–3583 for ‘‘Guide to Minimize
Food Safety Hazards of Fresh-cut
Produce: Draft Guidance for Industry.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
VerDate Sep<11>2014
16:58 Oct 19, 2018
Jkt 247001
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the Office
of Food Safety, Division of Produce
Safety, Center for Food Safety and
Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr.,
College Park, MD 20740. Send two selfaddressed adhesive labels to assist that
office in processing your request. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance.
FOR FURTHER INFORMATION CONTACT:
Insook Son, Center for Food Safety and
Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–1648.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of
a draft guidance for industry entitled
‘‘Guide to Minimize Food Safety
Hazards of Fresh-cut Produce.’’ We are
issuing the draft guidance consistent
with our good guidance practices
regulation (21 CFR 10.115). The draft
guidance, when finalized, will represent
the current thinking of FDA on this
topic. It does not establish any rights for
any person and is not binding on FDA
or the public. You can use an alternate
approach if it satisfies the requirements
of the applicable statutes and
regulations. This guidance is not subject
to Executive Order 12866.
The FDA Food Safety Modernization
Act (FSMA) (Pub. L. 111–353) enables
FDA to better protect public health by
helping to ensure the safety and security
of the food supply. FSMA enables FDA
to focus more on preventing food safety
problems rather than relying primarily
on reacting to problems after they occur.
FSMA recognizes the important role
industry plays in ensuring the safety of
the food supply, including the adoption
of modern systems of preventive
PO 00000
Frm 00008
Fmt 4702
Sfmt 4702
controls in food production. Section 103
of FSMA amended the Federal Food,
Drug, and Cosmetic Act (FD&C Act), by
adding section 418 (21 U.S.C. 350g)
with requirements for hazard analysis
and risk-based preventive controls for
establishments that are required to
register as food facilities under our
regulations in 21 CFR part 1, subpart H,
in accordance with section 415 of the
FD&C Act (21 U.S.C. 350d).
In 2008, we issued a guidance for
industry entitled ‘‘Guide to Minimize
Microbial Food Safety Hazards of Freshcut Fruits and Vegetables.’’ Fresh-cut
fruits and vegetables mean any fresh
fruit or vegetable or combination thereof
that has been physically altered from its
whole state after being harvested from
the field (e.g., by chopping, dicing,
peeling, ricing, shredding, slicing,
spiralizing, or tearing) without
additional processing (such as
blanching or cooking). That guidance
was intended for all fresh-cut produce
processing firms to enhance the safety of
fresh-cut produce by minimizing the
microbial food safety hazards. It
explained our thinking on how to
comply with CGMP requirements that
then were established in a regulation
entitled ‘‘Current Good Manufacturing
Practice in Manufacturing, Packing, or
Holding Human Food’’ (21 CFR part
110).
In the Federal Register of September
17, 2015 (80 FR 55908), we published a
final rule that, among other things,
modernized the CGMP requirements
and established them in new 21 CFR
part 117 (part 117), entitled ‘‘Current
Good Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive
Controls for Human Food.’’ Part 117
also includes new requirements for
hazard analysis and risk-based
preventive controls for establishments
that are required to register as food
facilities. The draft guidance that we are
making available for public comment is
intended to explain our current thinking
on how all food establishments that
produce fresh-cut produce can comply
with the modernized CGMP
requirements in part 117. The draft
guidance also is intended to explain our
current thinking on how fresh-cut
produce food facilities that are subject
to the new requirements for hazard
analysis and risk-based preventive
controls can comply with those
requirements.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
E:\FR\FM\22OCP1.SGM
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Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Proposed Rules
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in part 117 have been
approved under OMB control number
0910–0751.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/FoodGuidances or
https://www.regulations.gov. Use the
FDA website listed in the previous
sentence to find the most current
version of the guidance.
Dated: October 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–23005 Filed 10–19–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket Number USCG–2018–0948]
RIN 1625–AA00
Safety Zone; Delaware River; Camden,
NJ; Fireworks Display
Coast Guard, DHS.
Notice of proposed rulemaking.
AGENCY:
ACTION:
The Coast Guard proposes to
establish a temporary safety zone on a
portion of the Delaware River in
Camden, NJ. This action is necessary to
protect the surrounding public and
vessels on these navigable waters
adjacent to the Battleship New Jersey
Museum and Memorial, Camden, NJ,
during a fireworks display on November
14, 2018. This proposed rulemaking
would prohibit persons and vessels
from entering, transiting, or remaining
within the safety zone unless authorized
by the Captain of the Port Delaware Bay
or a designated representative. We
invite your comments on this proposed
rulemaking.
DATES: Comments and related material
must be received by the Coast Guard on
or before November 6, 2018.
ADDRESSES: You may submit comments
identified by docket number USCG–
2018–0948 using the Federal
eRulemaking Portal at http://
www.regulations.gov. See the ‘‘Public
Participation and Request for
Comments’’ portion of the
SUPPLEMENTARY INFORMATION section for
further instructions on submitting
comments.
daltland on DSKBBV9HB2PROD with PROPOSALS
SUMMARY:
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16:58 Oct 19, 2018
Jkt 247001
If
you have questions about this proposed
rulemaking, call or email Petty Officer
Thomas Welker, U.S. Coast Guard,
Sector Delaware Bay, Waterways
Management Division; telephone 215–
271–4814, email Thomas.j.welker@
uscg.mil.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
I. Table of Abbreviations
CFR Code of Federal Regulations
COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
§ Section
U.S.C. United States Code
II. Background, Purpose, and Legal
Basis
On September 14, 2018, Rexel, Inc
notified the Coast Guard that it will be
conducting a fireworks display from
8:35 p.m. to 8:55 p.m. on November 14,
2018. The fireworks are to be launched
from a barge in the Delaware River
adjacent to the Battleship New Jersey
Museum and Memorial, Camden, NJ.
Hazards from fireworks displays include
accidental discharge of fireworks,
dangerous projectiles, and falling hot
embers or other debris. The Captain of
the Port Delaware Bay (COTP) has
determined that potential hazards
associated with the fireworks to be used
in this display would be a safety
concern for anyone within a 600-foot
radius of the barge.
The purpose of this rulemaking is to
ensure the safety of vessels and the
navigable waters within a 600-foot
radius of the fireworks barge before,
during, and after the scheduled event.
The Coast Guard proposes this
rulemaking under authority in 33 U.S.C.
1231.
III. Discussion of Proposed Rule
The COTP is proposing to establish a
safety zone from approximately 8:15
p.m. through 9:15 p.m. on November 14,
2018. The safety zone would cover all
navigable waters within 600 feet of a
fireworks barge in the Delaware River
adjacent to the Battleship New Jersey
Museum and Memorial, Camden, NJ.
The barge will be anchored in
approximate position 39°56′20″ N
Latitude, 075°08′08″ W Longitude. The
duration of the zone is intended to
ensure the safety of vessels and these
navigable waters before, during, and
after the scheduled 8:35 p.m. to 8:55
p.m. fireworks display. No vessel or
person would be permitted to enter,
transit, or remain within the safety zone
without obtaining permission from the
COTP or a designated representative.
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53199
The regulatory text we are proposing
appears at the end of this document.
IV. Regulatory Analyses
We developed this proposed rule after
considering numerous statutes and
Executive orders related to rulemaking.
Below we summarize our analyses
based on a number of these statutes and
Executive orders and we discuss First
Amendment rights of protestors.
A. Regulatory Planning and Review
Executive Orders 12866 and 13563
direct agencies to assess the costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits.
Executive Order 13771 directs agencies
to control regulatory costs through a
budgeting process. This NPRM has not
been designated a ‘‘significant
regulatory action,’’ under Executive
Order 12866. Accordingly, the NPRM
has not been reviewed by the Office of
Management and Budget (OMB), and
pursuant to OMB guidance it is exempt
from the requirements of Executive
Order 13771.
This regulatory action determination
is based on the size, location, duration,
and time-of-day of the safety zone.
Vessel traffic would be able to safely
transit around this safety zone which
would impact a small designated area of
the Delaware River for one hour during
the evening when vessel traffic is
normally low. Moreover, the Coast
Guard would issue a Broadcast Notice to
Mariners via VHF–FM marine channel
16 about the zone, and the rule would
allow vessels to seek permission to enter
the zone.
B. Impact on Small Entities
The Regulatory Flexibility Act of
1980, 5 U.S.C. 601–612, as amended,
requires Federal agencies to consider
the potential impact of regulations on
small entities during rulemaking. The
term ‘‘small entities’’ comprises small
businesses, not-for-profit organizations
that are independently owned and
operated and are not dominant in their
fields, and governmental jurisdictions
with populations of less than 50,000.
The Coast Guard certifies under 5 U.S.C.
605(b) that this proposed rule would not
have a significant economic impact on
a substantial number of small entities.
While some owners or operators of
vessels intending to transit the safety
zone may be small entities, for the
reasons stated in section IV.A above,
this proposed rule would not have a
significant economic impact on any
vessel owner or operator.
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Agencies

[Federal Register Volume 83, Number 204 (Monday, October 22, 2018)]
[Proposed Rules]
[Pages 53197-53199]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23005]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 117
[Docket No. FDA-2018-D-3583]
Guide To Minimize Food Safety Hazards of Fresh-Cut Produce: Draft
Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the availability of a draft guidance for industry entitled
``Guide to Minimize Food Safety Hazards of Fresh-cut Produce.'' The
draft guidance, when finalized, will supersede a previous guidance,
entitled ``Guide to Minimize Microbial Food Safety Hazards of Fresh-cut
Fruits and Vegetables,'' that we issued in 2008. The draft guidance is
intended to explain our current thinking on how to comply with recently
modernized requirements for current good manufacturing practice (CGMP)
and with new requirements for hazard analysis and risk-based preventive
controls under our regulation entitled ``Current Good Manufacturing
Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human
Food'' during the production of fresh-cut produce.
DATES: Submit either electronic or written comments on the draft
guidance by April 22, 2019 to ensure that the Agency considers your
comment on the draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that
[[Page 53198]]
identifies you in the body of your comments, that information will be
posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2018-D-3583 for ``Guide to Minimize Food Safety Hazards of Fresh-
cut Produce: Draft Guidance for Industry.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the draft guidance to
the Office of Food Safety, Division of Produce Safety, Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740. Send two self-addressed adhesive labels to
assist that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance.
FOR FURTHER INFORMATION CONTACT: Insook Son, Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240-402-1648.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of a draft guidance for industry
entitled ``Guide to Minimize Food Safety Hazards of Fresh-cut
Produce.'' We are issuing the draft guidance consistent with our good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on this topic. It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternate approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.
The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353)
enables FDA to better protect public health by helping to ensure the
safety and security of the food supply. FSMA enables FDA to focus more
on preventing food safety problems rather than relying primarily on
reacting to problems after they occur. FSMA recognizes the important
role industry plays in ensuring the safety of the food supply,
including the adoption of modern systems of preventive controls in food
production. Section 103 of FSMA amended the Federal Food, Drug, and
Cosmetic Act (FD&C Act), by adding section 418 (21 U.S.C. 350g) with
requirements for hazard analysis and risk-based preventive controls for
establishments that are required to register as food facilities under
our regulations in 21 CFR part 1, subpart H, in accordance with section
415 of the FD&C Act (21 U.S.C. 350d).
In 2008, we issued a guidance for industry entitled ``Guide to
Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and
Vegetables.'' Fresh-cut fruits and vegetables mean any fresh fruit or
vegetable or combination thereof that has been physically altered from
its whole state after being harvested from the field (e.g., by
chopping, dicing, peeling, ricing, shredding, slicing, spiralizing, or
tearing) without additional processing (such as blanching or cooking).
That guidance was intended for all fresh-cut produce processing firms
to enhance the safety of fresh-cut produce by minimizing the microbial
food safety hazards. It explained our thinking on how to comply with
CGMP requirements that then were established in a regulation entitled
``Current Good Manufacturing Practice in Manufacturing, Packing, or
Holding Human Food'' (21 CFR part 110).
In the Federal Register of September 17, 2015 (80 FR 55908), we
published a final rule that, among other things, modernized the CGMP
requirements and established them in new 21 CFR part 117 (part 117),
entitled ``Current Good Manufacturing Practice, Hazard Analysis, and
Risk-Based Preventive Controls for Human Food.'' Part 117 also includes
new requirements for hazard analysis and risk-based preventive controls
for establishments that are required to register as food facilities.
The draft guidance that we are making available for public comment is
intended to explain our current thinking on how all food establishments
that produce fresh-cut produce can comply with the modernized CGMP
requirements in part 117. The draft guidance also is intended to
explain our current thinking on how fresh-cut produce food facilities
that are subject to the new requirements for hazard analysis and risk-
based preventive controls can comply with those requirements.
II. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of
[[Page 53199]]
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). The collections of information in part 117 have
been approved under OMB control number 0910-0751.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous
sentence to find the most current version of the guidance.
Dated: October 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23005 Filed 10-19-18; 8:45 am]
BILLING CODE 4164-01-P